ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
**This positon is located in West Point, PA.**
**Location - West Point, PA**
****Please Note: This role is considered an essential worker role and would require the individual to work onsite 5 days a week.****
**What will you be doing?**
You will be responsible for and to execute clinical packaging and labeling activities - including material prep, room and equipment staging, execution and documentation of operations, and room clearance and cleaning.
**What do you need to have?**
+ Perform complaint and deviation investigations, creation of appropriate CAPA's and drive CAPA's to closure.
+ Ensure clinical supplies are processed according to GMPs
+ Participate as subject matter expert during internal or external audits
+ Manage change control for existing packaging equipment
+ Coordinate re-evaluation (RED) dating extension request packaging campaigns
+ Perform several aspects of SOP Administration, including authoring SOP's and coordinating training activities
+ Manage the ordering and inventory levels for non-GMP packaging components (trays, ect..)
+ Manage projects for new technologies
+ Participate, facilitate, lead risk assessments
+ HS diploma required and bachelor degree preferred
+ Read, write and speak fluent English language.
+ 1-3 years applicable experience in GMP environment preferred but not required.
+ SAP experience a plus but not required.
+ 4 year degree preferered
+ Prior experience in either planning, labeling, packaging, and shipping of clinical supplies and work experience in a regulated environment preferred.
**Benefits of Working in ICON:**
Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
- Clinical Works
- External Audits
- Hardworking And Dedicated